NCT00869180

Brief Summary

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

January 28, 2010

Status Verified

January 1, 2010

Enrollment Period

4 months

First QC Date

March 24, 2009

Last Update Submit

January 26, 2010

Conditions

Acute PainAnkle Sprain

Keywords

diclofenacankle sprainacute paintopicalpatchAcute Pain due to Mild to Moderate Ankle Sprain

Outcome Measures

Primary Outcomes (1)

  • Change in average pain during daily activity at Day 3

    Day 3

Secondary Outcomes (1)

  • Change in average pain during daily activity at Day 7

    Day 7

Study Arms (2)

Diclofenac Sodium Patch

EXPERIMENTAL
Drug: Diclofenac Sodium

Topical Placebo Patch

PLACEBO COMPARATOR
Drug: Matching Placebo Patch

Interventions

Diclofenac SodiumDRUG

Topical diclofenac patch applied once daily to area of pain

Diclofenac Sodium Patch
Matching Placebo PatchDRUG

Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily

Topical Placebo Patch

Eligibility Criteria

Age17 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects 17 - 75 years of age
  • Sustained recent, painful unilateral mild to moderate ankle sprain
  • Meet baseline pain criterion

You may not qualify if:

  • Open wound or infection at site of injury
  • Evidence of severe injury or ankle fracture
  • Use of oral NSAIDs or opioids within 12 - 24 hours of injury
  • Presence or history of peptic ulcers or GI bleeding
  • A history of intolerance to NSAIDs, acetaminophen, adhesives
  • Positive pregnancy test
  • Positive drug screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD

Austin, Texas, 78704, United States

Location

MeSH Terms

Conditions

Acute PainAnkle Injuries

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 25, 2009

Study Start

February 1, 2009

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

January 28, 2010

Record last verified: 2010-01

Locations

US(1)